Developments in global non-invasive prenatal testing (NIPT) market

Commercial
non-invasive prenatal testing (NIPT) company Sequenom has acquired new global intellectual
property from Isis Innovation, the University of Oxford’s technology transfer
entity.

The transaction,
which gives Sequenom ownership of methods for ‘non-invasive prenatal genetic diagnostic testing on paternally
inherited fetal nucleic acids derived from maternal plasma or serum’, carried
a $14.55 million (over £9m million) price tag. This included $3.2 million in outstanding
license payments from Sequenom to Isis for previous exclusive rights to the use
of key NIPT intellectual property.

Isis held significant
intellectual property relating to NIPT derived from the original work of inventor
Professor Dennis Lo, then at the University of Oxford. Now
Sequenom owns NIPT patents not only for Europe, the US and Canada but also for
Japan, Hong Kong and Australia; the press release notes that the portfolio includes ‘valid
and enforceable’ patents for all of these regions except for the US. This is
because Sequenom
recently faced a set-back in terms of its intellectual property portfolio when
the US Patent and
Trademark Office invalidated
claims on a key US patent.

However, the purchase
of fresh IP suggests that the company believes that it can still make good
returns even if it has lost significant ground in the US market; earlier this
year they alluded to plans to create a low cost-test expected ‘to facilitate
international access and potential future entry into the low-risk market’.
Referring to the purchase from Isis, Chief Executive William Welch said: “We look forward to leveraging this
important intellectual property for additional applications of our technology In
the future”.

The Asia-Pacific
region is seen as an enormously important market for non-invasive prenatal
testing of both high-risk and low-risk maternal populations; some countries
such as Japan are showing a sharp trend towards older (and hence higher-risk for
fetal aneuploidy) mothers, whilst the sheer size of markets such as China and
India represent potentially massive returns for a successful product.

However, not only
are there already significant players for the Asian markets, but Asian
companies are also players in the Western market; Chinese sequencing monolith
BGI was recently granted a new patent for NIPT technology not only for
China by the State Intellectual Property Office of China, but also for Europe by the European Patent Office (EPO) in a ruling that applies to fifteen
member states including England, France and Germany. BGI became the first NIPT provider to
receive approval from
the China Food and Drug Administrationearlier this year, and is now the first mainland
Chinese registered company to have an NIPT patent approved by the EPO.